Senior Manager, Global Regulatory Process and Compliance

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $139.8k - $184.8k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 1%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Lead regulatory compliance programs that strengthen GRA’s compliance health, inspection readiness, regulatory information management, and proactive regulatory risk management • Independently assess compliance risks and trends, develop risk-based recommendations, and lead cross-functional initiatives through implementation and effectiveness monitoring • Partner with Global Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology • Provide oversight of Veeva RIM data stewardship and regulatory information quality • Monitor data quality and drive resolution of systemic information and process risks • Lead GRA readiness for audits and health authority inspections, including readiness assessments, SME preparation, audit/inspection support, post-audit assessments, trend analysis, and remediation oversight • Conduct GRA compliance risk assessments and maintain the compliance risk portfolio • Assess regulatory changes, health authority expectations, audit/inspection outcomes, and internal compliance issues for GRA impact • Provide compliance guidance and challenge practices creating regulatory or inspection-readiness risk • Monitor critical GRA processes, establish KPIs, thresholds, and escalation triggers, investigate recurring issues, and recommend corrective actions • Partner with Business Process Owners and SMEs to implement actions, assign ownership, track completion, and confirm effectiveness • Develop compliance KPIs, risk indicators, dashboards, escalation thresholds, and management reporting • Combine compliance data to identify recurring and emerging risks and report compliance health, risks, actions, owners, and status to GRA leadership and the Regulatory Compliance Network • Lead root-cause analysis and problem-solving for significant or recurring compliance issues • Develop practical guidance, tools, training, and lessons learned • Build compliance requirements into day-to-day processes and reinforce business ownership • Work independently, lead cross-functional initiatives, hold action owners accountable, and communicate risks and recommendations to senior leadership • May manage direct reports or contractors and provide mentorship, coaching, and guidance

🎯 Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Technology, or related discipline; advanced degree preferred • 7+ years of progressive experience in Regulatory Affairs, regulatory compliance, Quality, Regulatory Operations, or another GxP function within the pharmaceutical/biotechnology industry • Demonstrated experience independently leading compliance programs, risk assessments, audits/inspection readiness activities, remediation, and cross-functional improvement initiatives • Strong working knowledge of FDA, EMA, MHRA, PMDA and other global health authority expectations, ICH guidelines, applicable GxP requirements, 21 CFR Part 11, and ALCOA+ data integrity principles • Experience supporting or leading health authority inspections and internal audits • Demonstrated ability to perform root-cause analysis, compliance risk assessment, trend analysis, and effectiveness monitoring • Experience with Veeva Vault RIM/BRIM or comparable Regulatory Information Management platforms strongly preferred • Experience developing compliance KPIs, dashboards, trend analyses, and executive-level reporting • Strong analytical and problem-solving capabilities with demonstrated ability to translate data into actionable compliance recommendations • Strong project/program leadership, stakeholder management, facilitation, and organizational change capabilities • Ability to work independently, manage competing priorities, and exercise sound judgment in a complex global environment • Proficiency with regulatory information management systems such as Veeva RIM and electronic document management systems • Experience with compliance monitoring dashboards, data analytics, and reporting tools such as Power BI, Tableau, or equivalent • Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint, Outlook, Teams) • RAC, ASQ CQA, Six Sigma/Lean, project management, or comparable certification preferred • Travel: < 15%

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness